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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of aspirin
    		•  

    Primary Prevention Project study, 2001

    Treatments

    Studied treatment aspirin 100 mg/d
    Control treatment no aspirin (open control)
    Remarks factorial design with other comaprison: vitamin E vs control

    Patients

    Patients men and women aged 50 years or greater, with at least one of the major recognised cardiovascular risk factors.

    Method and design

    Randomized effectives 2226 / 2269 (studied vs. control)
    Design Factorial plan
    Blinding Open
    Follow-up duration 3.6 y
    Number of centre multicentre
    Hypothesis Superiority
    Primary endpoint cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke


    Results

    Endpoint Studied treat.
    n/N     Control treat.
    n/N     Graph RR [95% CI]

    Coronary event

    26 / 2226
         35 / 2269
         0,76 [0,46;1,25]

    stroke (fatal and non fatal)

    16 / 2226
         24 / 2269
         0,68 [0,36;1,28]

    Haemmorhagic stroke

    2 / 2226
         3 / 2269
         classic 0,68 [0,11;4,06]

    Cardiovascular events

    45 / 2226
         64 / 2269
         0,72 [0,49;1,04]

    Major gastrointestinal bleeding

    6 / 2226
         3 / 2269
         classic 2,04 [0,51;8,14]

    ischemic stroke

    14 / 2226
         15 / 2269
         0,95 [0,46;1,97]

    Coronary death

    11 / 2226
         13 / 2269
         0,86 [0,39;1,92]

    All cause death

    62 / 2226
         78 / 2269
         0,81 [0,58;1,13]

    Gastrointestinal Bleeding

    17 / 2226
         5 / 2269
         classic 3,47 [1,28;9,38]

    myocardial infarction (fatal and non fatal)

    19 / 2226
         28 / 2269
         0,69 [0,39;1,23]

    Non fatal MI

    15 / 2226
         21 / 2269
         0,73 [0,38;1,41]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 26 / 2226 (1,2%) 35 / 2269 (1,5%) 0,76 [0,46;1,25]    
    stroke (fatal and non fatal) 16 / 2226 (0,7%) 24 / 2269 (1,1%) 0,68 [0,36;1,28]    
    Haemmorhagic stroke 2 / 2226 (0,1%) 3 / 2269 (0,1%) 0,68 [0,11;4,06]    
    Cardiovascular events 45 / 2226 (2,0%) 64 / 2269 (2,8%) 0,72 [0,49;1,04]    
    Non fatal MI 15 / 2226 (0,7%) 21 / 2269 (0,9%) 0,73 [0,38;1,41]   10916 
    ischemic stroke 14 / 2226 (0,6%) 15 / 2269 (0,7%) 0,95 [0,46;1,97]   10916 
    Coronary death 11 / 2226 (0,5%) 13 / 2269 (0,6%) 0,86 [0,39;1,92]    
    All cause death 62 / 2226 (2,8%) 78 / 2269 (3,4%) 0,81 [0,58;1,13]    
    Gastrointestinal Bleeding 17 / 2226 (0,8%) 5 / 2269 (0,2%) 3,47 [1,28;9,38]    
    myocardial infarction (fatal and non fatal) 19 / 2226 (0,9%) 28 / 2269 (1,2%) 0,69 [0,39;1,23]    
    Major gastrointestinal bleeding 6 / 2226 (0,3%) 3 / 2269 (0,1%) 2,04 [0,51;8,14]   10916 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 10916: Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti AAspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials.Lancet 2009 May 30;373:1849-60

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 1,17% 1,54% -3,7‰
    stroke (fatal and non fatal) 7,19‰ 1,06% -3,4‰
    Haemmorhagic stroke 0,90‰ 1,32‰ -0,4‰
    Cardiovascular events 2,02% 2,82% -8,0‰
    Non fatal MI 6,74‰ 9,26‰ -2,5‰
    ischemic stroke 6,29‰ 6,61‰ -0,3‰
    Coronary death 4,94‰ 5,73‰ -0,8‰
    All cause death 2,79% 3,44% -6,5‰
    Gastrointestinal Bleeding 7,64‰ 2,20‰ 5,4‰
    myocardial infarction (fatal and non fatal) 8,54‰ 1,23% -3,8‰
    Major gastrointestinal bleeding 2,70‰ 1,32‰ 1,4‰


    Reference(s)

    Trials register # NA
    • de Gaetano G. Low-dose aspirin and vitamin E in people at cardiovascular risk: a randomised trial in general practice. Collaborative Group of the Primary Prevention Project.. Lancet 2001 Jan 13;357:89-95
      Pubmed | Hubmed | Fulltext

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